EPiC are expanding our range of virtual symposium events with the launch of our first GCP symposium on Thursday 24th September 2026.
EPiC’s view on applying evolving GCP requirements to help anticipate challenges and implement risk proportionate systems for conducting GCP compliant trials.
- Thursday 24th September 2026. 9:00 to 16:30 (GMT)
- £375.00 + VAT per delegate
- CPD Certified (In Principle)
- Access all event materials and recordings on demand following the event
EPiC is proud to present our first full-day virtual GCP symposium 2026 event featuring an esteemed line-up of former MHRA Inspector speakers.
The rapidly evolving clinical trial ecosystem has resulted in the most significant changes in clinical trial regulation in over 20 years.
The publication of ICH E6 R3 GCP guideline and the MHRA Clinical Trial Hub guidance to support the implementation of the UK Clinical Trial regulations, have provided useful resources to help Sponsors prepare for the changes, but the challenge facing most organisations is putting the theory into practice and how to implement risk proportionate systems to deliver GCP compliant trials.
Join us as we share the perspectives and experiences from former MHRA GCP Inspectors to provide insights into the most challenging aspects of applying evolving GCP requirements, to help delegates navigate the changes.
The ‘what and how’ format will focus on addressing the key objectives of ICH E6 R3 and ICH E8 R1 and will feature real world examples of applying Quality by Design (QbD), critical thinking, and proportionate ‘fit for purpose’ approaches to help delegates anticipate challenges, pre-empt and address potential problems to avoid them becoming GCP inspection deficiencies.
Expect an interactive and informal experience carefully crafted to include:
- Practical considerations for applying Risk Proportionate Approaches
- Data Governance – essential elements and effective oversight mechanisms
- Safety surveillance and reporting – applying a holistic approach to safety surveillance and reporting.
- Critical thinking – understanding and applying critical thinking skills to improve operational processes.
- Assessing E Systems – practical considerations for assessing fitness for purpose and GCP compliance for the non-CSV Auditor.
- Serious Breaches – exploring what is expected by regulators when assessing and triaging serious breaches to ensure the right things are being reported.
- Oversight of Delegated Activities – due diligence considerations for Sponsors for the selection and oversight of investigators and service providers.
- Q&A Panel Session
Our panel of experts, drawing on their extensive knowledge and regulatory experience are committed to delivering a thought-provoking and informative event with an emphasis on providing practical guidance. Engage with them throughout the day and participate in a panel session to ensure all your pressing questions are addressed.
Our objective is to combine valuable insights using real world examples and collective experiences to provide the knowledge and offer practical solutions to help take you beyond the basics and propel your organisation towards excellence in clinical trial conduct and compliance.
The event is ideal for clinical trial professionals involved in QA, Study Management, Clinical Operations, Study Monitoring, Data Management, Pharmacovigilance and Safety oversight from Sponsor and Service Provider organisations.
It is particularly relevant for those seeking to strengthen their understanding of regulatory expectations, improve day to day compliance practices, or enhance their ability to influence GCP outcomes within their organisation.
The event will reflect on the evolving clinical trial ecosystem and the significant changes following the publication of ICH E6 R3 GCP guideline and UK Clinical Trial regulations and provide practical guidance on how to implement risk proportionate systems to deliver GCP compliant trials.
We will explore in detail the expectations and requirements relating to Data Governance, Safety Surveillance, E Systems, Serious Breaches and Oversight of Outsourced Activities and provide practical guidance and solutions to close compliance gaps. We will share personal insights on how companies can effectively ensure and demonstrate the compliance status through the practical application of risk proportionate approaches and help you understand how QbD and critical thinking can be successful deployed to improve the quality of operational processes to benefit trial participants and GCP compliance.
Through presentations, case studies and Q&A sessions, highlighting regulatory expectations, industry best practice and example scenarios, you will learn how to navigate the evolving GCP requirements, anticipate challenges, pre-empt and address potential problems to avoid them becoming GCP inspection deficiencies.
LEARN how to utilise practical solutions to overcome GCP compliance challenges
CONNECT with former MHRA GCP Inspectors and EPiC Consultants
COLLABORATE with other delegates involved in clinical research
ENGAGE in our presentations and panel discussions and hear Clinical Trial case studies from our regulatory experts
CPD Continuous Professional Development to improve workplace skills and knowledge
VALUE for money, presenting a wide range of topics from regulatory experts
9:00 – 9:10
(10 mins)
Welcome and Introductions
Richard Andrews
9:10 – 10:00
(50 mins)
Practical Considerations for Applying Risk Proportionate Approaches
Paula Walker
10:00 – 10:45
(45 mins)
Data Governance – Essential Elements and Effective Oversight
Kath Williams
10:45 – 11:00
(15 mins)
Coffee Break
11:00 – 11:50
(50 mins)
Safety Surveillance and Reporting
Louise Mawer
11:50 – 12:30
(40 mins)
Applying Critical Thinking to Improve Operational Processes
Michelle Yeomans
12:30 – 13:30
(60 mins)
Lunch
13:30 – 14:15
(45 mins)
Assessing E Systems for the Non-CSV Auditor
Kath Williams
14:15 – 15:00
(45 mins)
Serious Breaches – Understanding the What, Why and How for Serious Breach Reporting
Jenny Martin
15:00 – 15:15
(20 mins)
Coffee Break
15:15 – 16:00
(45 mins)
Oversight of Delegated Activities – Due Diligence Considerations for Sponsors
Louise Mawer
16:00 – 16:20
(20 mins)
Q&A Panel Session
Expert panel answer your burning questions
16:20 – 16:30
(10 mins)
Closing Remarks
Richard Andrews
Michelle Yeomans
Richard Andrews
Jennifer Martin
Kath Williams
Louise Mawer
Paula Walker
Register
If you need to pay offline, please contact enquiries@epic-auditors.com
Non-UK delegates: If you are registering on behalf of a business or individual outside the UK and require an invoice, please select “Request to Pay Offline” and contact us. We will review your VAT status and issue an invoice in accordance with the applicable VAT rules.
